Quality Assurance Operations Specialist

Thermo Fisher Scientific Inc.; Monza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical industry seeks a Quality Operations Specialist to support the Qualified Person in ensuring compliance with quality standards. The role involves reviewing documentation, managing deviations, and handling customer complaints while adhering to GMP and FDA regulations. Ideal candidates will have a degree in a scientific field and strong interpersonal skills.

Competenze

• Degree in Chemistry, Pharmacy, Biology or similar scientific fields.
• Knowledge of pharmaceutical production and control processes.

Mansioni

• Supports Qualified Person in assessing product batches and environment.
• Reviews GMP deviations and handles customer complaints.
• Acts as point of contact for Quality Assurance aspects.

Conoscenze

Teamwork

Interpersonal Skills

English

Formazione

Degree in Chemistry

Degree in Pharmacy

Degree in Biology

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

SCOPE AND RESPONSIBILITIES:

Under the supervision of the relevant QOPS Team Leader and QOPS Supervisor, supports the Qualified Person in assessing product batches and the working environment by verifying documentation and other necessary information.

Following the guidance and coordination of the Team Leader, reviews GMP deviations and handles customer complaints in compliance with standards, company procedures, and current regulations (laws, GMP standards, FDA, etc.).

Acts as the point of contact with the customer regarding Quality Assurance aspects related to commercial productions.

SPECIFIC TASKS/PRIMARY ACTIVITIES:

Preparation for Release of Commercial Batches and Conformity Assessment

• Under the guidance and coordination of the Team Leader, ensures batch compliance with specifications by completing release Check Lists in accordance with SOPs, current regulations (laws, GMP, FDA, etc.), and company quality standards.
• Supports the Team Leader, PQ, and Senior Quality Operations Manager in batch release by providing conformity judgments based on document verification, complying with current regulations and standards.

Management of Deviations and Investigation Reports

• Reviews deviations from the production process to ensure high standards in compliance with SOPs and regulations.
• Contributes, with relevant functions, to identifying and evaluating corrective and preventive actions to effectively close deviations according to quality standards and procedures.
• Supports the archiving and management of batch records and deviation documentation according to the Quality System and company procedures.
• Acts as the point of contact with the customer regarding the status of production process deviations.

Handling Complaints

• Investigates customer complaints to understand causes and identify appropriate corrective or preventive actions, collaborating with support functions (production, maintenance, QC), aiming to maximize customer satisfaction while respecting SOPs, regulations, and customer agreements.
• Acts as the point of contact with the customer regarding complaint status updates.

Support for Audits

• Assists the Team Leader in preparing and managing customer and regulatory audits.

Quality

• Operates in accordance with company quality standards, applying relevant procedures and policies.

REQUIREMENTS AND QUALIFICATIONS:

ESSENTIAL

Education/Training:

• Degree in Chemistry, Pharmacy, Biology, or similar scientific fields.

Technical and IT skills:

• Knowledge of pharmaceutical production and control processes.
• Understanding of GMP/FDA regulations.
• Proficiency in written and spoken English.
• Ability to work in a team and excellent interpersonal skills.